P1083: BRENTUXIMAB VEDOTIN, ETOPOSIDE, SOLUMEDROL, HIGH DOSE ARA-C &amp; PLATINUM FOLLOWED BY HDT &amp; APBSCT FOR REFRACTORY/RELAPSED HODGKIN LYMPHOMA PATIENTS: LONG-TERM RESULTS OF THE GELTAMO GROUP BRESHAP STUDY
Authors: R. Garcia-Sanz, C. Martínez, F. De la Cruz, A. P. González, A. Rodríguez, B. Sánchez-González, E. Domingo-Domenech, M. Moreno, J. López, J. L. Piñana, M. Bastos, M. Canales, A. Gutiérrez, M. J. Rodríguez-Salazar, A. Navarro, A. Sureda
Journal: HemaSphere (2022)

Background: For Refractory/Relapsed Hodgkin Lymphoma (RRHL) patients, the combination of BRentuximab vedotin, Etoposide, Solumedrol, High dose Ara-C and Platinum (BRESHAP) as induction therapy prior to high-dose therapy and Autologous Stem Cell Transplantation (APBSCT) induces an overall (OR) and complete remission (CR) rate of 93% and 71% of patients with an initial 75% Time to Tumor Progression at three years (Garcia-Sanz et al, Ann Oncol 2019). In these patients, the primary efficacy endpoint is usually the CR pre-APBSCT, but long-term results including time to tumor progression (TTP) or overall survival are challenges that should be evaluated in these recently adopted strategies. Aims: In this work, we evaluate long-term results of the phase II trial with the combination of BV and ESHAP [BRESHAP] as 2nd line therapy for RRHL prior to APBSCT (ClinicalTrials.gov #NCT02243436). Methods: Data update with an additonal follow-up period of four years compared with the initial publication in the EHA-2018 congress Results: The trial included 66 patients with relapsed or refractory classical HL (cHL) who had failed to one prior line of therapy were eligible. There were 35 females & 31 males, with a median age of 36 years (18-66). Forty patients were primary refractory, 16 early relapses (CR ≤1 year) and 10 late relapses (CR >1 year). During the follow-up, excluding progressions, there were 39 Severe Adverse Events (SAEs) reported in 22 patients (hospitalizations and AEs around transplant were not considered SAEs), which means that no new SAEs were reported after the initial publication of the results. Transplant was done after BRESHAP in 61 patients with no problems reported about the engraftment in the long-term evaluation. As reported, pre-transplant OR was 93% (including a 71% CR). At a mean follow-up of 75 months, 16 patients have progressed and 3 died without progression, providing 7-year time to treatment failure (TTP) and progression free survival (PFS) of 74% and 70%, respectively. Eight patients have died: 5 due to progression, and the 3 due to complications in the absence of relapse or refractory disease: pneumonia, sepsis and pulmonary embolism. The overall survival (OS) at seven year was 88% (figure 2). There were three variables related to a lower PFS and TTP: CR after BRESHAP, bone marrow infiltration at relapse/refractoriness and B symptoms at inclusion in the trial. In the multivariate analysis, only response to BRESHAP maintained the independent predictive capacity. Respect to OS, the only prognostic factor was CR to 2nd line therapy Image:Summary/Conclusion: BRESHAP followed by high dose therapy and autologous peripheral blood stem transplant is a safe and effective strategy for patient with refractory or relapsed Classical Hodgkin lymphoma with excellent long-term results.